Objectives: To analyze the complications of first 400 laparoscopic
cholecystectomies (LC) for patients with symptomatic gall stone disease
at a tertiary care hospital.

Study Design: Quasi-experimental study.

Place and Duration of Study: PNS Shifa Karachi and CMH Lahore
Pakistan from Nov 2009 to Jan 2013.

Patients and Methods: A prospective analysis of complications
occurring in first 400 consecutive laparoscopic cholecystectomies by a
single consultant/unit at a tertiary care hospital was made. Out of
total 421 patients presenting with symptomatic gall stone disease in a
single unit 21 cases that underwent open cholecystectomy were excluded
from the study. Laparoscopic Cholecystectomies were performed using
three port and four port technique and data including age sex diagnosis
number of trocar placements conversion to open surgery and its reasons
operative time post-operative hospital stay and complications was
collected on personal computer and analyzed using Statistical package
for social sciences (SPSS) version 13.

Conclusion: Laparoscopic Cholecystectomy is associated with some
serious complications which can be avoided with adequate training of
surgeons as well as knowledge of mechanism of typical complications.

Cholecystectomy is one of the most commonly performed abdominal
surgical procedures and in developed countries many are performed
laparoscopically. Ninety percent of cholecystectomies in the United
States are performed laparoscopically1. Laparoscopic cholecystectomy is
considered the "gold standard" for the surgical treatment of
symptomatic gallstone disease2. This procedure results in less
postoperative pain better cosmesis shorter hospital stay and early
return to work than open cholecystectomy3. Although LC is a procedure of
choice for treatment of gallstones due to its advantages but it is
sometimes associated with serious and life threatening complications.
Many complications of LC are similar to those occurring during
traditional Open Cholecystectomy (OC) such as hemorrhage bile leak bile
duct injuries missed stones acute pancreatitis wound infections and
incisional hernias at trocar site.

The risk of intraoperative bile duct injury during laparoscopic
cholecystectomy is higher than in open cholecystectomy4 but it is
anticipated that this will decrease with experience of surgeons.
Similarly the spectrum of complications in gallstone surgery has also
changed: typical minimally invasive surgery-related complications due to
trocars such as vascular and bowel injuries complications associated
with the pneumoperitoneum as well as procedure-related complications
have raised morbidity to 2.9%5. The spectrum of mishaps has also changed
due to the involvement of new instruments such as stapling devices
coagulation shears and sealing systems6. Complications like migrating
clips7 or stenosis of the common bile duct (CBD) due to a wrongly
applied clip were completely unknown in open surgery. Recently an
unreported case of duodeno-cutanoeus fistula has been seen due to a
wrongly placed clip to the wall of duodenum.

This study presents a 3 years' experience of laparoscopic
cholecystectomy with special emphasis to the pattern of complications
and morbidity related to this procedure.

PATIENTS AND METHODS

This prospective study was carried out at surgical department PNS
Shifa Karachi and CMH Lahore over a period of three years from November
2009 to January 2013. Patient selection for LC was based upon clinical
diagnosis findings of ultrasound examination laboratory investigations
and anesthetist's assessment. All patients with symptomatic
gallstones acute cholecystitis and empyema gallbladder were included.
Patients with upper abdominal surgery perforated gallbladder with
abscess formation cholecystocoduodenal fistula and preoperative
diagnosis of carcinoma gall bladder cardiopulmonary disease equipment
failure and those with choledocholithiasis were excluded from the study.
Out of 421 cases with symptomatic gall stones 94% were laparoscopic
cholecystectomies and 6% underwent open cholecystectomy. Hypertension
diabetes mellitus hypothyroidism and ischemic heart disease were the
most common co-morbidities.

Laparoscopic cholecystectomy was performed by using single chip
camera and later high definition camera by Karl Storz. Pneumoperitoneum
was established by closed method using Veress needle in 80% cases or
open technique in 20% cases. Number of trocars used for LC was three
(83%) or four (15.8%). SILS was used in only 1.2% of cases. Majority of
LC were performed by using a modified three port technique called
sectorization rather than triangulation with 10 mm umbilical camera port
a 5mm dissecting port 4-5 cm below xiphoid sternum and a third 5mm port
in left rather than right midclavicular line 10-15 cm away from
umbilicus for holding Hartmann's pouch in most of the cases. Fourth
port for holding fundus of gall bladder was used only in a few difficult
cases with very long gall bladder. Drains were placed in few cases where
bile leak or bleeding was suspected. Three doses of injectable
antibiotics were given in all cases.

All cases were mobilized the same evening and those without
complications were discharged next morning. Data was collected on
computer and analyzed using SPSS version 13. The collected data included
age sex diagnosis number of trocar placements conversion to open surgery
and its reasons operative time post-operative hospital stay and
postoperative complications. Follow up was done on 5th 10th and 30th
day. All the patients were asked to report to the author's OPD in
case of any late complications after 30th day of operation.

RESULTS

Total 400 patients with gallstones underwent laparoscopic
cholecystectomies in the study period. The age of patients ranged from 9
years to 78 years with median age of 44 years. Out of 400 cases 84.3%
(n=337) were female and 15.7% (n=63) were male with female to male ratio
5.3: 1. Depending upon the preoperative diagnosis and laparoscopic
findings patients had diagnosis of Chronic cholecystitis / biliary colic
68.25% (n=- 273) acute cholecystitis 23.75% (n=95) and empyema gall
bladder 7.25% (n=29). There were two cases with gallstone pancreatitis
and one with mucocele gall bladder. Post operatively two cases were
diagnosed as carcinoma gall bladder on histopathology. A rare case
having situs inversus cholelithiasis and acute appendicitis underwent
laparoscopic surgery. Most common co-morbidities were hypertension 8.5%
(n=34) combined diabetes mellitus and hypertension 3.5% (n=14)

There was one hospital death due to myocardial infarction on 2nd
post-operative day.

DISCUSSION

Laparoscopic cholecystectomy is the procedure of choice for
majority of patients with symptomatic gallstones disease. In our study
94% patients had LC and 6% OC which is in consistent with other
studies1. With advances in laparoscopic instruments and technique
refinements this procedure is getting safer and safer and morbidity and
mortality is decreasing day by day. Some of serious complications
related to LC are discussed. In 2.5% to 14% of cases conversion of LC to
OC is needed8-10due to massive bleeding bile duct injuries obscure
anatomy bowel injuries and cholecystoduodenal fistula although surgeons
do not consider it a complication. In this study conversion rate was
1.25%.Bleeding is one of the commonest complications of LC. Overall
incidence of uncontrolled bleeding during LC is 0.1% to 1.9%. and can
occur from three sites i.e. from trocar insertion site

From liver bed due to close proximity of middle hepatic vein or its
radicals to gallbladder fossa in up to 10 to 15% of patients8 and from
injury to vessels especially cystic artery which has high association
with right hepatic arterial injury. Bleeding from trocar insertion site
usually occurs after removal of trocar when pneumoperitoneum is reduced.
It is recommendedthat removal of trocars should be done under vision
after reducing pneumoperitoneum. Incidence of major vascular injury
involving aorta iliac vessels vena cava inferior mesenteric arteries and
lumbar arteries is 0.07%0.4%9. The mortality rate due to bleeding is
0.05%0.2%10. In our study frequency of uncontrolled bleeding was 1.25%.
In two cases intraoperative bleeding occurred from cystic artery injury
and in another case there was continued oozing of blood from liver bed;
these three cases were converted to open cholecystectomy.

In 4th case bleeding occurred from omental injury during trocar
insertion which was missed during operation unfortunately. Patient
presented with acute abdomen on 1st post op day and laparotomy had to be
performed to identify and manage the cause. Another case presented with
haemo- peritoneum two weeks postoperatively and laparotomy revealed
oozing from liver bed due to undiagnosed coagulopathy. There was no
major vessel injury in our series.

Bile leak usually results from injuries that involve leakage into
the gallbladder bed from either the minor hepatic ducts or the cystic
duct most often due to clip failure. Incidence can be reduced by using
locking clips11. Problem is usually suspected whenever there is delay in
recovery or there is uncommon post-operative course. Ultrasonography
MRCP ERCP and PTC will usually help in identifying the complication and
its location12. Frequency of bile leak in our study was 0.5% (n=2).
First case presented with biliary peritonitis on 1st post-operative day
and laparotomy revealed slippage of clip from cystic duct stump. Second
patient presented with sub- hepatic collection on 8th post-operative day
and exploratory laparotomy was done for biloma and cause could not be
identified. Peritoneal lavage was done and patient made uneventful
recovery.

Major bile duct injury is most serious and most common reported
complication. Incidence varied in different studies depending upon
surgeon's experience. It is predicted that a surgeon had a 1.7%
chance of a bile duct injury occurring in the first case and 0.17%
chance of a bile duct injury in the 50th case13. In addition to the
surgeon's experience other factors include aberrant anatomy chronic
inflammation with dense scarring operative bleeding obscuring the field
or fat in the portal area contributing to the biliary injuries14. Most
of these lesions are diagnosed postoperatively usually later than in
open cholecystectomy. This is a major problem because besides
surgeon's experience early diagnosis and primary repair gives the
best results15. We recommend availability of intra- operative
cholangiogram at all laparoscopic centers especially during the learning
curve of surgeons for the early diagnoses of all such injuries.

In our study we had only one case (0.25%) of common hepatic duct
(CHD) injury due to an accidental tear in its anterior wall which was
identified preoperatively and a T tube was placed laparoscopically.
However case was converted to open to ascertain the exact nature of
injury. Our incidence of bile duct injury is at par with other studies.
Late post-operative strictures result from excessive use of diathermy
near the CBD or following biliary reconstructions for injuries during
cholecystectomy16. We did not get any case of post-operative biliary
stricture in our study.

Bowel injury usually occurs during trocar insertion and rarely
during dissection of adhesions or with diathermy. Incidence is 1 to 4
per 1000 laparoscopic cholecystectomies17. Injuries that are identified
per-operatively or those presenting with acute abdomen in post-
operative period are managed by laparotomy and primary repair.
Alternatively in cases where the presentation is more indolent and
controlled standard enterocutaneous fistula management with nutritional
support and adequate drainage and wound care is also appropriate. There
was no case of bowel injury in our study.

Spilled gallstone is relatively common complication in LC.
Estimated incidence is 10% and 30%18. However most of the cases remain
silent. Rarely these stones present with secondary complications. The
most frequent one is intra- abdominal abscess formation followed by
abdominal wall infection or permanent sinus19. Some other serious
complications reported in the literature are small bowel obstruction20
incarceration in a hernia sac21 and trans- diaphragmatic migration that
results in pleural empyema or expectoration of bile and pus22. In our
study no secondary complication of stone spillage was seen. Port site
hernia is another complication which was seen in one case (0.25%) in our
study. Herniation occurred on 3rd post- operative day through umbilical
port site due to excessive coughing. Extraction of gallbladder through
epigastric port reduces the incidence of port site hernia by preventing
the enlargement of umbilical port.

One of the advantages of minimally invasive surgery is reduced
post-operative wound infection i.e. 2% as compared to 8% in open
cholecystectomy24. Frequency of port site infection in our study was 2%
(n=8). All eight cases of port site infection were managed with wound
toilet drainage and daily dressings with appropriate antibiotics. In our
study there was one case of subphrenic abscess for which laparotomy was
done. One case developed subcutaneous fat necrosis right flank around
the drain site.

In the present study all major postoperative complications five in
number including hemorrhage (1%) bile leakage (1%) and suspected acute
peritonitis (0.5%) requiring reoperation occurred during first 100
consecutive laparoscopic cholecystectomies. Only one patient had
undergone reoperation during last 300 consecutive laparoscopic
cholecystectomy procedures. Laparoscopic cholecystectomy has reduced the
hospital stay and is being performed as outpatient procedure due to easy
and less painful recovery. In this study the average hospital stay was
1.2 days which ranged from 1 to 20 days. This study clearly showed that
laparoscopic cholecystectomy can be performed safely and effectively.
This indicates that all cases of gallstones either complicated or not
can be treated laparoscopically and complication rate is reduced by the
increased experience and skills of the surgeon.

CONCLUSION

Laparoscopic cholecystectomy is associated with some very serious
complications to the patient which were completely unknown during the
era of open cholecystectomy. However adequate training of surgeons as
well as knowledge of mechanism of typical complications with low
threshold for conversion to open makes it effective and safe procedure
with low morbidity and mortality.